Cl II NeuViz 64 Multi-Slice CT Scanner

Company: Neusoft Medical Systems Co., Ltd.
Date of Enforcement Report 5/18/2016
Class lI:

PRODUCT

NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Recall Number Z-1650-2016

REASON
It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn’t meet the patient position description, when the scanner position was set to “Right” in the system setting – scanner options.

RECALLING FIRM/MANUFACTURER
Neusoft Medical Systems Co., Ltd. , Shenyang China on 5/2/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7 units

DISTRIBUTION
US Distribution – Including Puerto Rico and the states of IL, CT, SC, NE

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